Heart Failure Clinical Trial
VentrAssistTM LVAD for the Treatment of Advanced Heart Failure – Destination Therapy
Summary
The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.
This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
Full Description
Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.
Eligibility Criteria
Inclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):
Eligible for either the VentrAssist or an FDA-approved DT LVAD
LVEF <=25%
Stage D heart failure
Ineligible for cardiac transplantation
Treated with standard heart failure therapy
Exclusion Criteria (The following are general criteria; detailed criteria are included in the study protocol):
Contraindication to LVAD implantation
Contraindication to anticoagulant or anti-platelet agents.
Pre-existing mechanical circulatory support other than intra-aortic balloon pump
Therapy with an investigational intervention at the time of screening
A condition, other than heart failure, which would limit survival to less than 2 years
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There are 26 Locations for this study
Birmingham Alabama, 35294, United States
Phoenix Arizona, 85054, United States
Gainesville Florida, 32610, United States
Miami Florida, , United States
Chicago Illinois, 60611, United States
Indianapolis Indiana, 46260, United States
Baltimore Maryland, 21201, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55904, United States
St. Louis Missouri, 63110, United States
Newark New Jersey, 07112, United States
Bronx New York, 10467, United States
New York New York, 10029, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15213, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Falls Church Virginia, 22042, United States
Seattle Washington, 98185, United States
Spokane Washington, 99204, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53215, United States
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